BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGM

    MDR report key: 11328043 · Received February 15, 2021

    Report

    Report Number
    9680746-2021-00018
    Event Type
    Malfunction
    Date Received
    February 15, 2021
    Date of Event
    February 2, 2021
    Report Date
    February 15, 2021
    Manufacturer
    CLARE DISCRETE MFG IO
    Product Code
    QKO
    UDI-DI
    15099590738617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FILL PATIENT IDENTIFIER IS CASE-(B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS WEIGHT, ETHNICITY OR RACE. THE ACCESS SARS-COV-2 IGM REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SERVICE WAS DISPATCHED. FIELD SERVICE ENGINEER (FSE) VERIFIED CALIBRATION, CONTROLS, SYSTEM CHECK AND PIPETTING. NO HARDWARE MALFUNCTION WAS OBSERVED. THE CUSTOMER WAS ADVISED TO MAKE SURE THEIR PRE-ANALYTICAL SAMPLE HANDLING PROCESS IS CORRECTLY FOLLOWED. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2021 THE CUSTOMER REPORTED ONE NON-REPRODUCIBLE REACTIVE SARS-COV-2 IGM (ACCESS SARS-COV-2 IGM ASSAY, PART NUMBER C58957, LOT NUMBER 971287) RESULT WAS GENERATED ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE ACCESS RESULT OF 11.49 S/CO (REPORTABLE RANGE: REACTIVE =1.0 S/CO) WAS OBTAINED ON (B)(6) 2021. UPON REPEAT THE FOLLOWING DAY, A RESULT AT 0.14 S/CO WAS OBTAINED ON SAME ANALYZER AND A RESULT AT 0.18 S/CO WAS OBTAINED ON INSTRUMENT SERIAL NUMBER (B)(4). THE SAMPLE WAS REPEATED AGAIN ON (B)(6) 2021 ON INITIAL INSTRUMENT WITH A RESULT AT 0.17 S/CO. THE SARS-COV-2 IGG RESULT IS NON-REACTIVE AND IS NOT QUESTIONED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULT WAS REPORTED OUT OF THE LABORATORY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON (B)(6) 2021 WITH REAGENT LOT 971287 AND CALIBRATOR LOT 922427. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. CARRYOVER TEST PASSED ON (B)(6) 2021. SYSTEM CHECK PASSED ON (B)(6) 2021. SERVICE WAS DISPATCHED. FIELD SERVICE ENGINEER (FSE) VERIFIED CALIBRATION, CONTROLS, SYSTEM CHECK AND PIPETTING. NO HARDWARE MALFUNCTION WAS OBSERVED. THE CUSTOMER WAS ADVISED TO MAKE SURE THEIR PRE-ANALYTICAL SAMPLE HANDLING PROCESS IS CORRECTLY FOLLOWED. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, CENTRIFUGATION, STORAGE AND OTHER SAMPLE RELATED INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224819 ACCESS SARS-COV-2 IGM IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO CLARE DISCRETE MFG IO 971287 15099590738617

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR